Senior Associate, Product Engineer

Sun Pharmaceuticals, Inc; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in the United States is seeking a Mechanical Engineer to provide support for existing medical products and new projects. The role involves performing tests, maintaining documentation, and ensuring quality compliance. Candidates should have a BS in Mechanical Engineering and at least 7 years of relevant experience in the medical device industry. Strong problem-solving skills and technical interpretation abilities are essential. This position offers exposure to dynamic work environments including labs and manufacturing areas.

Qualifications

• 7 years of experience in the medical device industry and/or biomedical field preferred.
• Ability to interpret and resolve technical and design issues required.

Responsibilities

• Provide support for existing products and investigate product issues.
• Prepare and maintain product documentation and specifications.
• Perform mechanical tests to ensure compliance with industry standards.
• Participate in project teams for plan definition and tracking.

Skills

Mechanical Engineering

Problem-solving

Technical interpretation

Team collaboration

Education

BS in Mechanical Engineering

Associates in Mechanical Engineering

Tools

Microsoft Office

Solid Works

Job description

Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.

Area Of Responsibility:

• Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements

• Prepare and maintain all necessary product documentation including product specifications, bills of material, hazard/risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers

• Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate

• Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects

• Ensure that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc.)

• Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements

• Contribute to new and supplemental regulatory submissions

• Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required

• Contribute ideas or generate Intellectual Property submissions

• Other duties as assigned

Performs all principle duties that affect the quality of products and services provided by DUSA Pharmaceuticals, Inc. within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business.

Work Conditions:

• Office

• Lab

• Manufacturing area/clean room area

• Maintenance Shop

• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell

• Close, distance and peripheral vision; depth perception, ability to focus

• Ability to operate production equipment and hand tools

• Operate hand truck

• Operate computer/office equipment

• Wear proper lab gowning and safety shoes

• Lifting and moving of heavy boxes/equipment up to 70 lbs.

Travel Estimate: Up to 10%

Education and Job Qualification:

• BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered

• Ability to interpret and resolve technical and design issues required

Experience:

• 7 years of experience in the medical device industry and/or biomedical field preferred

• Familiar with QSR / GMP regulations

• Experience with Microsoft Office Tools and Solid Works required

• Pharmaceutical industry experience a plus

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.